Ejaculatory Abstinence in IUI Cycles

NCT04361292 | Completed

• 1 other identifier: 60116787-020/17327
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Intrauterine insemination (IUI) combined with ovarian stimulation, has been an extensively used procedure for the treatment of patients with unexplained infertility. The aim of this study was to report the effect of ejaculatory abstinence on sperm DNA fragmentation and pregnancy rates in IUI cycles, as well as the correlation between the two.

Conditions

Infertility; Spermatozoa; Reproductive Disorder

Keywords

Intrauterine insemination; Ejaculatory abstinence; sperm DNA fragmentation; TUNEL assay

Outcome Measures

Primary Outcomes (1)

• pregnancy rate

  The presence of one or more gestational sacs on transvaginal ultrasonography was described as clinical pregnancy.

  The pregnancy test was done 14 days after intrauterine insemination. If the test was positive, transvaginal ultrasonography was performed at 6-7 weeks of gestation.

Secondary Outcomes (1)

• Sperm DNA fragmentation percentage

  On the day of IUI, semen samples were obtained and the sperm DNA fragmentation was measured by the TUNEL method in the inseminated sperm.

Study Arms (2)

Group A: one day abstinence period

ACTIVE COMPARATOR

Patients allocated into group A had an ejaculatory abstinence period of one day

Procedure: INTRAUTERINE INSEMINATION

Group B: three days abstinence period

ACTIVE COMPARATOR

Patients allocated into group B had an ejaculatory abstinence period of three days

Procedure: INTRAUTERINE INSEMINATION

Interventions

INTRAUTERINE INSEMINATION PROCEDURE

Intrauterine insemination (IUI) combined with ovarian stimulation, has been an extensively used procedure for the treatment of patients with unexplained infertility. The fact that IUI is less expensive, less invasive, and easier to perform than other assisted reproductive techniques makes it the first-line treatment option in infertility treatments. Sperm that have been washed and concentrated are placed directly into the uterus around the time of ovulation. All patients had ovulation induction with gonadotropins and ovulation was triggered by recombinant hcg.

Group A: one day abstinence period; Group B: three days abstinence period

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Couples with the diagnosis of unexplained infertility.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Infertility for more than 12 months
• Diagnosed as unexplained infertility
• Female age between 20 and 40 years
• Regular menstrual cycles
• Mid-luteal progesterone levels of \>3 ng/ml
• Basal FSH \<12 mIU/ml, AMH \>1ng/ml
• Body mass index (BMI) 19-35 kg/m2
• No pelvic pathology documented by transvaginal ultrasound and bilateral tubal patency diagnosed by hysterosalpingography
• Normal semen parameters according to WHO criteria

You may not qualify if:

• Any endocrine and pelvic pathology
• PCOS (polycystic ovarian syndrome)
• Known endometriosis history
• Prior pelvic surgery
• Persistent ovarian cysts.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Faculty of Medicine, Obstetrics and Gynecology Department, Infertility Center

Denizli, Turkey (Türkiye)

Location

Related Publications (4)

• Jurema MW, Vieira AD, Bankowski B, Petrella C, Zhao Y, Wallach E, Zacur H. Effect of ejaculatory abstinence period on the pregnancy rate after intrauterine insemination. Fertil Steril. 2005 Sep;84(3):678-81. doi: 10.1016/j.fertnstert.2005.03.044.

  PMID: 16169402 BACKGROUND

• Marshburn PB, Alanis M, Matthews ML, Usadi R, Papadakis MH, Kullstam S, Hurst BS. A short period of ejaculatory abstinence before intrauterine insemination is associated with higher pregnancy rates. Fertil Steril. 2010 Jan;93(1):286-8. doi: 10.1016/j.fertnstert.2009.07.972. Epub 2009 Sep 3.

  PMID: 19732887 BACKGROUND

• Thomson LK, Zieschang JA, Clark AM. Oxidative deoxyribonucleic acid damage in sperm has a negative impact on clinical pregnancy rate in intrauterine insemination but not intracytoplasmic sperm injection cycles. Fertil Steril. 2011 Oct;96(4):843-7. doi: 10.1016/j.fertnstert.2011.07.356. Epub 2011 Aug 11.

  PMID: 21839433 BACKGROUND

• Kabukcu C, Cil N, Cabus U, Alatas E. Effect of ejaculatory abstinence period on sperm DNA fragmentation and pregnancy outcome of intrauterine insemination cycles: A prospective randomized study. Arch Gynecol Obstet. 2021 Jan;303(1):269-278. doi: 10.1007/s00404-020-05783-0. Epub 2020 Sep 9.

  PMID: 32902676 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• CIHAN KABUKCU, M.D.

  Department of Obstetrics and Gynecology - Infertility Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: From the randomization list, an independent secretary who was blind to patients' identities applied the allocation in consecutive order. Patients allocated into group A, and group B. Care provider and investigator were blind to patient groups. Participants were informed about the timing of abstinence intervals, but they did not know which groups they were allocated to.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, M.D.

Model Details: One hundred twenty eligible couples were prospectively randomized into two groups on the second day of the cycle just before starting the treatment protocol. Randomization was performed according to a computer-generated random number list at a ratio of 1:1. From the randomization list, an independent secretary who was blind to patients' identities applied the allocation in consecutive order. Patients allocated into group A, had an ejaculatory abstinence period of one day, whereas patients allocated into group B had an ejaculatory abstinence period of three days.

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: January 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: February 29, 2020
• Last Updated: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)